VOX/BASE FOR WINDOWS

• K Number: K972933
• Device Name: VOX/BASE FOR WINDOWS
• Manufacturer: J-MAC SYSTEM, INC.
• Date Cleared: 1997-10-27 ( 80 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended Use

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). It is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities.

Device Description

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). The software consists of four modules: Query, Receive, View and Manager.

Predicate Devices

K962699

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard PACS system with basic image processing capabilities and does not mention any AI or ML features.

Therapeutic

No

The device is a Picture Archival and Communication System (PACS) software designed for viewing, storing, and transmitting medical images, not for treating diseases or conditions.

Diagnostic

No
Explanation: The device is a PACS (Picture Archival and Communication System) intended for viewing, storing, and transmitting medical images. It performs basic image processing but does not provide diagnostic interpretations or clinical findings.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "stand alone software product" and the intended use reinforces this by describing its function as a software-based PACS system. There is no mention of accompanying hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the software is for viewing, retrieving, storing, processing, and transmitting medical images. It is described as a Picture Archival and Communication System (PACS).
• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Lack of Biological Sample Analysis: The description of the device and its intended use does not involve the analysis of any biological samples. It focuses solely on the management and display of medical images generated by various imaging modalities.

Therefore, the J-MAC VOX/BASE for Windows, as described, falls under the category of medical imaging software or a PACS, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities. The J-MAC system is an accessory to diagnostic imaging devices, it is not a diagnostic device. The J-MAC VOX/BASE System User Manual provides warnings and precautions regarding intended use, and detailed information on system operation.

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). It is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities.

Product codes (comma separated list FDA assigned to the subject device)

90 LLZ

Device Description

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS).

The software consists of four modules: Query, Receive, View and Manager. The function of each is as follows:

• 1. Query This module implements the Query and Retrieve DICOM Services as a Service Class User. It calls functions in the WinSock library to connect to a remote Image Server using the TCP/IP network protocol.
• 2. Receive This module implements the Storage DICOM Services as a Service Class provider. It calls functions in the WinSock library to accept connections from a remote Service Class User using the TCP/IP network protocol.
• 3. View this module contains tools for
  • basic image processing (flipping, rotating, inverting) .
  • screen layout (cell dimensions and arrangement, colors, font) .
  • image management (magnifying lens, zoom, select, hide, scroll) ●
• 4. Manager This module provides a convenient way of knowing which images are already stored locally.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT), Magnetic Resonance Imaging (MRJ), Computed Radiography (CR), Digital Subtraction Angiography (DS), Nuclear Medicine (NM), Ultrasound (US), Endoscopy (ES), Radiographic imaging (RG), and other modalities.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical professionals working in image analysis and management. Hospitals, clinics, physicians office and other health care settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K962699

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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J-MAC VOX/ BASE System 510(k) Notification

OCT 27 1997

510(k) Summary

K972933

J-MAC VOX/BASE System for Windows

Common classification name: Digital Image Communications System (PACS)

J-MAC Systems, Inc. Oda Building 10-1 Kita 9 Nishi 3 Kita-ku, Sapporo, 060, Japan Phone: [phone] Fax:

Contact Person:

Sheila W. Pickering Ph.D. 320 Fairway Drive Half Moon Bay, California 94019 Telephone/Fax [phone]

A. Legally Marketed Predicate Device

The J-MAC VOX/BASE for Windows is substantially equivalent to the RadWorks Medical Imaging Software (K962699) manufactured by Applicare Imaging, Inc, as well as other PACS systems. The J-MAC device is substantially equivalent to the RadWorks predicate device with regard to device features and specifications, as well as intended use. Both devices are stand alone PACS software systems with similar operating requirements, and both comply with DICOM 3.0 and ACR-NEMA 2.0. Both are Windows based applications. Both products are intended for use with Computed Tomography (CT), Magnetic Resonance Imaging (MRJ), Computed Radiography (CR), Digital Subtraction Angiography (DS), Nuclear Medicine (NM), Ultrasound (US), Endoscopy (ES), Radiographic imaging (RG), and other modalities.

,

B. Device Description

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS).

The software consists of four modules: Query, Receive, View and Manager. The function of each is as follows:

• 1. Query This module implements the Query and Retrieve DICOM Services as a Service Class User. It calls functions in the WinSock library to connect to a remote Image Server using the TCP/IP network protocol.

1

• 2. Receive This module implements the Storage DICOM Services as a Service Class provider. It calls functions in the WinSock library to accept connections from a remote Service Class User using the TCP/IP network protocol.
• 3. View this module contains tools for
  • basic image processing (flipping, rotating, inverting) .
  • screen layout (cell dimensions and arrangement, colors, font) .
  • image management (magnifying lens, zoom, select, hide, scroll) ●
• 4. Manager This module provides a convenient way of knowing which images are already stored locally.

C. Intended Use

The device is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities. The J-MAC system is an accessory to diagnostic imaging devices, it is not a diagnostic device. The J-MAC VOX/BASE System User Manual provides warnings and precautions regarding intended use, and detailed information on system operation.

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J-MAC VOX/ BASE System 510(k) Notification

D. Substantial Equivalence

	Predicate Device	Submission Device
Product Name	RadWorks Medical Imaging Software
K962699	J-MAC VOX/Base/Windows
Medical Imaging Software	Substantially
Equivalent
Intended Users	Medical professionals working in image
analysis and management	Medical professionals working in image
analysis and management	yes
Site of Use	Hospitals, clinics, remote health care
facilities	Hospitals, clinics, remote health care
facilities	yes
Languages	English	Japanese and English	yes
Software structure	Modular design	Modular design (4 modules: Query, Receive, View, Manager)	yes
Compliance with
standards	Complies with DICOM 3.0 and
ACR-NEMA 1.0 or 2.0 or proprietary	Complies with DICOM 3.0 and
ACR-NEMA 1.0 or 2.0 or proprietary	yes
Operating System	Microsoft Windows NT	Microsoft Windows 95, Windows NT3 3.51, 4.0 or later	yes

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1997

Sheila W. Pickering, Ph.D. J-MAC Systems, Inc. c/o Wilson Sonsini Goodrich & Rosati 320 Fairway Drive Half Moon Bay, CA 94019

Re:

K972933

VOX/BASE™ for Windows Dated: August 5, 1997 Received: August 8, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Dr. Pickering:

We have reviewed your Section 5100k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.T. Kiau Yui

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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J-MACVON BASF. 510(k) Notification

FDA Submission Cover Sheet

510(k) Number (if known): Not applicable

Device Name J-MAC VOX/BASE for Windows

Indications For Use:

The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). It is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrance Of CDRH, Office Of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number	K972933
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